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510(k) K855131

SUTURE REMOVAL KIT by Dynarex Corp. — Product Code JOK

K855131 is an FDA 510(k) premarket notification submitted by Dynarex Corp. for the device "SUTURE REMOVAL KIT". The FDA issued a decision of Substantially Equivalent on January 13, 1986. The device falls under product code JOK (Scissors, Medical, Disposable), a Class I device regulated under 21 CFR 880.6820. Dynarex Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1986
Date Received
December 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scissors, Medical, Disposable
Device Class
Class I
Regulation Number
880.6820
Review Panel
HO
Submission Type

Other clearances by Dynarex Corp.

  • K052743 — DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 (December 22, 2005)
  • K052314 — DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE (November 9, 2005)
  • K012816 — DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 (October 17, 2002)
  • K012957 — TOWEL DRAPE, MODELS 4409, 4410 (March 6, 2002)
  • K012917 — DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B (November 28, 2001)
  • K991695 — DYNAREX NON-WOVEN SPONGE (July 15, 1999)
  • K991694 — DYNAREX DRAIN SPONGE (July 15, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K960388 — DYNAREX NON-WOVEN SPONGE (April 1, 1996)
  • K951660 — DYNAREX GAUZE SPONGE (May 9, 1995)

Other clearances for product code JOK

  • K843075 — UTILITY SCISSORS DISPOSABLE ITEMS (September 5, 1984)
  • K812555 — DISPOSABLE SUTURE REMOVAL SCISSORS (November 16, 1981)
  • K770595 — SUTURE REMOVAL SET (May 23, 1977)
  • K770481 — SHEAR, PLASTIC HANDLE UTILITY S-475-7 (April 29, 1977)
  • K770163 — SUTURE CUTTER (March 30, 1977)
  • K761192 — DRESSING CHANGE KIT (February 28, 1977)

FDA data resources